Pharmacodynamic Effects of a Free-Fatty Acid Formulation of Omega-3 Pentaenoic Acid in Adults With Hypertriglyceridemia

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacodynamic effects of MAT9001 compared to Vascepa in adults with hypertriglyceridemia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Collaborators: Matinas Biopharma, Inc; MB Clinical Research and Consulting LLC
• Treatments: Eicosapentaenoic acid ethyl ester

Criteria

Inclusion Criteria:

• Male or female, ≥18 y of age

• Judged to be in generally good health

• Fasting triglycerides ≥150 mg/dL to ≤499 mg/dL during screening

• Body mass index of ≥20.0 kg/m2

• No clinically significant findings in a 12-lead ECG or physical examination

• Willing and able to undergo the scheduled study procedures

• Understands study procedures and signs forms documenting informed consent to participate in the study

Exclusion Criteria:

• Laboratory test result of clinical significance

• Uncontrolled hypertension

• Clinically significant gastrointestinal, endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, or biliary disorder

• History of human immunodeficiency virus, hepatitis B or hepatitis C infection

• Used any medication intended to alter the lipid profile within 4 weeks of the first qualification visit

• Active systemic infection

• A condition the Investigator believes would interfere subject ability to provide informed consent and/or comply with the study protocol